FDA Steps Up Actions Against Hi-Tech 38797

FDA Steps Up Actions Against Hi-Tech

NORCROSS, Ga.U.S. marshals, acting on a complaint filed by theU.S. Attorneys Office for the Northern District of Georgia at the behest ofthe Food and Drug Administration (FDA), seized approximately $3 million ofephedra-containing dietary supplements and raw materials from Hi-TechPharmaceuticals facilities here. The products, including Lipodrene,Stimerex-ES and Betadrene, were labeled as containing 25 mg of ephedrinealkaloids per tablet. According to FDA, the seizure included more than 200 casesof finished product, more than 200 boxes of bulk tablets and nine 25-kilo drumsof ephedrine alkaloid raw material.

Hi-Tech filed a lawsuit in U.S. District Court in August 2005 against FDA toprohibit the agency from enforcing its original rule and requesting it followthe Utah decision. FDA is seeking to dismiss the lawsuit on the grounds thatHi-Tech was not involved in the Utah case; however, Hi-Techs president, JaredWheat, told INSIDER the company filed its response to FDAs motion todismiss on Feb. 21, alleging the agency is venue shopping to find a courtthat will uphold its original ephedra decision. The next day, FDA asked theGeorgia authorities to execute the seizure in Norcross. Wheat added Hi-Techfiled an injunction requesting the release of the product while the case is inlitigation. We still contend dietary supplements containing ephedra are safeand effective when used as directed, Wheat said. He added the agency hasconducted more than a dozen inspections of the Norcross facility since August2005, with no action at that location until now, although the company has workedwith retailers who had Hi-Tech products seized by FDA during the past sixmonths.